Study of Ruxolitinib in Solid Organ Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma
Status:
Not yet recruiting
Trial end date:
2023-05-31
Target enrollment:
Participant gender:
Summary
In this open-label, multicenter, Phase II study, the investigators propose to evaluate the
efficacy of ruxolitinib, an orally administered inhibitor of JAK1/2, in solid organ
transplant recipients with advanced cSCC. In a safety lead-in of 6 patients, subjects will
receive ruxolitinib 15mg twice daily (BID). After 4 weeks, if dose-limiting toxicities (DLT)
are observed in 1 or fewer patients, the study will enter stage 1 of the Simon two-stage
design where all subsequent patients will receive a starting dose of ruxolitinib 15mg BID. If
more than 1 DLTs are observed, another cohort of 6 patients will be treated at a dose of 10mg
BID. If less than 2 DLTs are observed at the new dose of 10mg, then the study will proceed to
stage I using this dose; otherwise the study will stop.